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Lansoprazole enteric-coated capsule and preparation method thereof

A technology of lansoprazole enteric and lansoprazole, which is applied in the field of lansoprazole enteric-coated capsule composition and its preparation, can solve problems such as high substance content and poor long-term storage stability, and achieve high storage stability, The effect of low content of related substances and high drug safety

Active Publication Date: 2017-02-01
HEBEI IDEAL & HIGHTECH PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But, based on reasons such as prescription composition, preparation process, the lansoprazole enteric-coated capsule in the prior art still has problems such as higher content of related substances, poor long-term storage stability, etc.

Method used

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  • Lansoprazole enteric-coated capsule and preparation method thereof
  • Lansoprazole enteric-coated capsule and preparation method thereof
  • Lansoprazole enteric-coated capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-4

[0107] Embodiment 1-4 Lansoprazole enteric-coated capsule of the present invention

[0108] prescription:

[0109]

[0110] Note: In Examples 1-3, the weight ratio of magnesium carbonate and L-HPC in the drug-loaded layer is 1:1.

[0111] Preparation:

[0112] (1) Preparation of blank pellet cores

[0113] Using coating granulator and atomizing spray technology, sucrose, starch and 40% sucrose syrup (adhesive) are used to make 24-30 mesh blank pellet cores;

[0114] (2) Preparation of drug-loaded pellets

[0115] Dissolve the lansoprazole, sucrose, starch, magnesium carbonate, and L-HPC of the drug-loaded layer in pure water to obtain a drug-containing solution; use a multifunctional granulation bed coater to spray the resulting drug-containing solution on the aforementioned blank The surface of the pellet core is dried and cooled to obtain 14-25 mesh drug-loaded pellets;

[0116] (3) Preparation of isolation pellets

[0117] The sucrose, starch, and HPC of the isolat...

experiment example

[0122] Experimental example Lansoprazole enteric-coated capsules quality and storage stability research

[0123] Get the lansoprazole enteric-coated capsules that embodiment 1-4 makes, commercially available lansoprazole enteric-coated capsules, and the lansoprazole enteric-coated pellet capsules prepared by CN104523648A embodiment 1, at 40 ℃ ± 2 ℃, relative humidity of 75% ± 5% stored for 12 months, the test results of the percentage of related substances (%) are as follows:

[0124]

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PUM

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Abstract

The invention provides a lansoprazole enteric-coated capsule composition and a preparation method thereof. The lansoprazole enteric-coated capsule comprises lansoprazole, sucrose, starch, 40% sucrose syrup, magnesium carbonate, L-HPC, HPC, Eudragit L30D-55, talcum powder and sodium hydroxide. The lansoprazole enteric-coated capsule composition has the advantages of low content of relevant substances, high storage stability, high medication safety, simple preparation process, and suitableness for industrial production.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a lansoprazole enteric-coated capsule composition and a preparation method thereof. Background technique [0002] Lansoprazole (Lansoprazole) is the second proton pump inhibitor anti-ulcer drug after omeprazole. Its structure is similar to omeprazole. A trifluoroethoxy group is introduced on carbon 4. Due to the introduction of fluorine element, its acid-suppressing effect is stronger, and it is better than omeprazole in terms of chemical stability and therapeutic effect. Lansoprazole is suitable for treating gastric ulcer, duodenal ulcer, reflux esophagitis, Zollinger-Ellison syndrome, and anastomotic ulcer. The chemical name of Lansoprazole: (±)-2[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl] Benzimidazole, formula C 16 h 14 f 3 N 3 o 2 S, the structural formula is as follows: [0003] [0004] In the prior art, a lot of research...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/50A61K31/4439A61K47/02A61K47/38A61P1/04A61P1/00
CPCA61K9/501A61K9/5026A61K9/5047A61K9/5078A61K31/4439
Inventor 张云升郭艳丽胡竹梅夏彤
Owner HEBEI IDEAL & HIGHTECH PHARMA
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